[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559069":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":60,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":24,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":24,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Risk-based management strategy without invasive coronary angiography","EXPERIMENTAL","Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.",[13],"Diagnostic Test: Risk-based CAD management",{"label":15,"type":6,"description":16,"interventionNames":17},"Routine invasive coronary angiography","Routine invasive coronary angiography prior to TAVI. Percutaneous coronary intervention (PCI) recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.",[18],"Diagnostic Test: Invasive coronary angiography",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Risk-based CAD management",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Invasive coronary angiography","Routine invasive coronary angiography prior to TAVI. PCI recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.",[15],[30],{"name":31,"affiliation":32,"role":33},"Jonas Lanz, MD, MSc","University of Bern","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Jonas Lanz, MD MSc","CONTACT","+41 31 632 21 11","jonas.lanz@insel.ch",{"name":41,"role":37,"phone":24,"phoneExt":24,"email":24},"Thomas Pilgrim, MD MPH",[43],{"facility":44,"status":45,"city":46,"state":24,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Hospital Bern, Department of Cardiology","RECRUITING","Bern","3010","Switzerland","CH",{"type":51,"coordinates":52},"Point",[53,54],7.44744,46.94809,{"lat":54,"lon":53},[57],{"name":31,"role":37,"phone":24,"phoneExt":24,"email":24},{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[61,64],{"name":62,"class":63},"Clinical Trials Unit Bern (CTU)","UNKNOWN",{"name":65,"class":6},"Schweizerische Herzstiftung","100559069","coronary-artery-disease-assessment-strategies-in-tavi-patients-100559069",false,"NCT06559332","Coronary Artery Disease Assessment Strategies in TAVI Patients","Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation","CAT","Inclusion:\n\n• Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m\u002Fs\n\nOR\n\nif mean gradient \\\u003C40 mmHg and peak velocity (Vmax) \\\u003C4 m\u002Fs and stroke volume indexed to body surface area (SVi) ≤ 35 mL\u002Fm2 and LVEF ≥50% then if CT-derived aortic valve calcium score \\>2000 Agatston units in men, \\>1200 in women\n\nOR\n\nif mean gradient \\\u003C40 mmHg and Vmax \\\u003C4 m\u002Fs and SVi ≤ 35 mL\u002Fm2 and LVEF \\\u003C50% then if CT-derived aortic valve calcification \\>2000 Agatston units in men, \\>1200 in women OR if low-dose dobutamine stress echocardiography with flow reserve (\\>20% increase in stroke volume) and AVA ≤1cm2\n\n* Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease\n* Selected for treatment with transfemoral TAVI.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention\n* Unprotected left main coronary stenosis \\>50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT\n* Left ventricular ejection fraction (LVEF) \\\u003C 30%\n* New regional wall motion abnormalities on echocardiography\n* Myocardial infarction in previous 12 months\n* Coronary angiography in previous 12 months\n* Prior left main stenting","ALL","70 Years",{"count":77,"type":78},546,"ESTIMATED","INTERVENTIONAL",[81],"NA","Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.\n\nAs the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit\u002Frisk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear.\n\nThe CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).",[84,85,86],"Transcatheter Aortic Valve Replacement","Coronary Artery Disease","Heart Disease Risk Factors","2026-05-07",{"date":89,"type":90},"2026-05-08","ACTUAL",{"date":92,"type":90},"2025-03-11",{"date":94,"type":78},"2032-03-31",{"name":5,"class":6},1]